# K093479: Disposable Suction and Irrigation System

- Pathway: 510(k) (Traditional)
- Applicant: Modern Medical Equipment Mfg., Ltd.
- Decided: May 19, 2010 after 191 days
- Product code: FHF (System, Evacuator, Fluid)
- Device class: 2
- Regulation: 21 CFR 876.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Applied SI Suction Irrigator: named in the summary without a submission number

## Indications for use
The Disposable Suction And Irrigation System is used to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to remove fluid waste, tissue debris and smoke from the surgical site.

Source page: https://510kreport.com/device/K093479
Methodology: https://510kreport.com/methodology